Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia

NCT ID: NCT00206128

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

454 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-02-28

Brief Summary

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The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Seroquel SR

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A stable dose of quetiapine IR between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (Visit 1) as judged by the investigator.
* Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
* Able to understand and comply with the requirements of the study, as judged by the investigator.

Exclusion Criteria

* Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation.
* Patients with substance abuse or dependence, as defined by DSM-IV, and not in full remission. A urine drug screen test will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
* Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the investigator.
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Birmingham, Alabama, United States

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Anaheim, California, United States

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Cerritos, California, United States

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Garden Grove, California, United States

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National City, California, United States

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Pasadena, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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North Miami, Florida, United States

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Atlanta, Georgia, United States

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Hoffman Estates, Illinois, United States

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New Orleans, Louisiana, United States

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Jackson, Mississippi, United States

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Clementon, New Jersey, United States

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Staten Island, New York, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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QLD, , Australia

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Burgas, , Bulgaria

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Radnevo, , Bulgaria

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Varna, , Bulgaria

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Vancouver, British Columbia, Canada

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Aurora, Ontario, Canada

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Burlington, Ontario, Canada

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Mississauga, Ontario, Canada

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Orléans, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Prince Albert, Saskatchewan, Canada

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Põltsamaa, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Helsinki, , Finland

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Mikkeli, , Finland

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Turku, , Finland

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München, Bavaria, Germany

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Göttingen, Lower Saxony, Germany

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Research Center

Aachen, North Rhine-Westphalia, Germany

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Aachen, North Rhine-Westphalia, Germany

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Jena, Thuringia, Germany

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Halle, , Germany

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Marburg, , Germany

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Budapest, , Hungary

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Debrecen, , Hungary

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Gyula, , Hungary

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Nagykálló, , Hungary

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Szeged, , Hungary

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Székesfehérvár, , Hungary

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Bologna, BO, Italy

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Cagliari, CA, Italy

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Città di Castello, PG, Italy

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Ellera Di Corciano, PG, Italy

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Torino, TO, Italy

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Bassano del Grappa, VI, Italy

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Quartu Sant'Elena, , Italy

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Riga, , Latvia

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Sigulda, , Latvia

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Ziegzdrai, Kaunas County, Lithuania

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Klapeda, , Lithuania

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Šiauliai, , Lithuania

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Research Sitte

Vilnius, , Lithuania

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Jerez de la Frontera, Cádiz, Spain

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Alcobendas, Madrid, Spain

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Colmenar Viejo, Madrid, Spain

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Madrid, Madrid, Spain

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Móstoles, Madrid, Spain

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Villamartín, , Spain

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Countries

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United States Australia Bulgaria Canada Estonia Finland Germany Hungary Italy Latvia Lithuania Spain

Other Identifiers

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D1444C00146

Identifier Type: -

Identifier Source: org_study_id

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